Hybrid QC Instrumentation Specialist for cGMP Equipment

PE Global; Dublin; Hybrid; EUR 65,000 - 80,000; Full time

Job summary

PE Global is recruiting a QC Instrumentation Specialist for a leading multinational pharma client in South Dublin. This hybrid contract role focuses on planning, executing, and documenting qualification, calibration, and routine maintenance of laboratory systems in a cGMP QC environment at Amgen Dun Laoghaire.

You will manage the CMMS Maximo, author validation lifecycle documents, and perform data integrity testing.

Qualifications

• 3+ years of laboratory experience in a cGMP environment.
• Exposure to instrument validation and data integrity assessments.
• Understanding of regulatory requirements for cGMP equipment validation and electronic records.

Responsibilities

• Plan, execute and document calibration, qualification and maintenance of lab equipment per CMMS Maximo.
• Plan, execute and document qualification of new lab equipment in a cGMP environment, including writing validation protocols and reports.
• Conduct periodic reviews of instrument validation as part of the lifecycle.
• Alert QC management if equipment fails calibration/qualification and assess impact.
• Coordinate repairs/maintenance with vendors to minimize downtime.
• Support change controls and data integrity assessments for lab systems.

Skills

Calibration

Validation

Data Integrity

cGMP Knowledge

Education

Bachelor's degree in Science

Tools

Maximo CMMS

Job description

PE Global is recruiting a QC Instrumentation Specialist for a leading multinational pharma client in South Dublin. This hybrid contract role focuses on planning, executing, and documenting qualification, calibration, and routine maintenance of laboratory systems in a cGMP QC environment at Amgen Dun Laoghaire.

You will manage the CMMS Maximo, author validation lifecycle documents, and perform data integrity testing.